MRI for Tumor During Chemoradiation for Anal Canal and Perianal Cancer

Withdrawn

• Conditions: Anal Cancer Patients; Perianal Patients
• Interventions: Other: Magnetic Resonance Imaging (MRI)

• Registration Number: NCT01053923
• Lead Sponsor: University Health Network, Toronto

Brief Summary

The purpose of this study is to establish a prospective database of anal canal and perianal cancer patients treated with IMRT and chemotherapy with curative intent at PMH for the purposes of investigating MRI-derived primary tumor parameters. Patients who decide to participate in this study will be treated according to standard treatment policies and radiation therapy planning protocols at Princess Margaret Hospital (PMH) with radiation therapy +/- chemotherapy. IMRT for all treatment phases of radiotherapy has been implemented as standard treatment. Surgery is reserved for salvage treatment.

Detailed Description

Anal cancer is an uncommon cancer, accounting for 2% of gastrointestinal cancers. Prognostic factors include tumor differentiation and staging, along with patient gender, race, and socioeconomic status. The standard of care is radical chemoradiation with 5-fluorouracil and mitomycin C, with surgery reserved for salvage. Intensity modulated radiation therapy (IMRT) is a specialized radiotherapy technique that may be used for anal cancer. IMRT allows the radiation dose to conform to the three-dimensional shape of the target volume more than conventional two-dimensional techniques, and it may reduce treatment toxicities without compromising tumor control. At the Princess Margaret Hospital (PMH) since July 2007, IMRT for all treatment phases of radiotherapy has been implemented as standard treatment for patients with anal canal and perianal cancer.

Study Timeline

• Study Start: 2009-12
• Study First Submitted: 2010-01-21
• Study First Submitted QC: 2010-01-21
• Study First Posted: 2010-01-22
• Primary Completion: 2013-03
• Study Completion: 2013-03
• Status Verified: 2013-06
• Last Update Submitted: 2013-06-11
• Last Update Posted: 2013-06-13

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• histological confirmation of invasive primary squamous cell carcinoma or adenocarcinoma of the anal canal or perianal region
• treatment with curative intent
• patients who are not eligible for chemotherapy and receive IMRT alone are eligible for evaluation
• primary anal or perianal cancer evaluable on cross-sectional imaging (CT or MRI) scan
• ECOG performance status of 0, 1, or 2
• age > 18 years
• able to provide informed consent

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Exclusion Criteria

• evidence of distant metastasis (M1)
• prior radiation therapy to the pelvis or contraindication to radiotherapy
• contraindication to MRI imaging
• known allergy to intravenous Gadolinium
• renal insufficiency (serum creatinine greater than 150)
• serious claustrophobia
• cardiac pacemaker
• hip prosthesis
• major medical or psychiatric illness which, in the investigator's opinion, would prevent completion of imaging study

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
MRI Scan	Magnetic Resonance Imaging (MRI)	-

Primary Outcome Measures

Name	Time	Method
Primary tumor dimensions at simulation and during week 3 and last week of fractionated radiotherapy from MRI	12 months
Primary tumor perfusion coefficient at simulation and during week 3 and last week of fractionated radiotherapy from MRI	12 months
Primary tumor apparent diffusion coefficient at simulation and during week 3 and last week of fractionated radiotherapy from MRI	12 months

Secondary Outcome Measures

Name	Time	Method
Change with time from start of radiotherapy course in primary tumor dimensions from MRI	12 months
Change with time from start of radiotherapy course in primary tumor perfusion coefficient from MRI	12 months
Change with time from start of radiotherapy course in primary tumor apparent diffusion coefficient from MRI	12 months